Developing and evaluating complex interventions: new guidance. (2008). www.mrc.ac.uk/complexinterventionsguidance. Accessed 18 September 2013
Cook JA (2009) The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 10:9
PubMed Central
PubMed
Article
Google Scholar
Glossary of Cochrane terms. http://www.cochrane.org/glossary. Accessed 18 September 2013
Wang D, Bakhai A (2006) Clinical trials: a practical guide to design, analyis, and reporting. Remedica, London
Google Scholar
Cordoba G, Schwartz L, Woloshin S, Bae H, Gotzsche PC (2010) Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. British Medical Journal 341. doi:10.1136/bmj.c3920
Ross S (2007) Composite outcomes in randomized clinical trials: arguments for and against. Am J Obstet Gynecol 196(2):e1–e6
Article
Google Scholar
Montori VM, Permanyer-Miralda G, Ferreira-Gonzalez I, Busse JW, Pacheco-Huergo V, Bryant D, Alonso J, Akl EA, Domingo-Salvany A, Mills E, Wu P, Schunemann HJ, Jaeschke R, Guyatt GH (2005) Validity of composite end points in clinical trials. Br Med J 330(7491):594–596. doi:10.1136/bmj.330.7491.594
Article
Google Scholar
CONSORT Glossary. http://www.consort-statement.org/resources/glossary/. Accessed 18 September 2013
Savovic J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, Als-Nielsen B, Balk EM, Gluud C, Gluud LL, Ioannidis JPA, Schulz KF, Beynon R, Welton N, Wood L, Moher D, Deeks JJ, Sterne JAC (2012) Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies. Health Technol Assess 16(35):1–82. doi:10.3310/hta16350
CAS
PubMed
Google Scholar
Ciani O, Buyse M, Garside R, Pavey T, Stein K, Sterne JAC, Taylor RS (2013) Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study. British Medical Journal 346. doi:10.1136/bmj.f457
Mpabanzi L, van Mierlo KMC, Malago M, Dejong CHC, Lytras D, Damink S (2013) Surrogate endpoints in liver surgery related trials: a systematic review of the literature. HPB 15(5):327–336. doi:10.1111/j.1477-2574.2012.00590.x
PubMed
Article
Google Scholar
Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, Balliol C (2009) Surgical innovation and evaluation 2. Challenges in evaluating surgical innovation. Lancet 374(9695):1097–1104
PubMed Central
PubMed
Article
Google Scholar
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J, Balliol C (2009) Surgical innovation and evaluation 3. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374(9695):1105–1112
PubMed
Article
Google Scholar
Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A (2013) IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. Br Med J 346:f2820. doi:10.1136/bmj.f2820
Article
Google Scholar
Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K (2009) A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 62(5):464–475. doi:10.1016/j.jclinepi.2008.12.011
PubMed
Article
Google Scholar
Patsopoulos NA (2011) A pragmatic view on pragmatic trials. Dialogues Clin Neurosci 13(2):217–224
PubMed Central
PubMed
Google Scholar
Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ (2009) Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet 374(9695):1067–1073. doi:10.1016/s0140-6736(09)61115-6
PubMed
Article
Google Scholar
Lilford R, Braunholtz D, Harris H, Gill T (2004) Trials in surgery. Br J Surg 91(1):6–16. doi:10.1002/bjs.4418
CAS
PubMed
Article
Google Scholar
Pibouleau L, Boutron I, Reeves BC, Nizard R, Ravaud P (2009) Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review. British Medical Journal 339. doi:10.1136/bmj.b4538
Ellis C, Hall JL, Khalil A, Hall JC (2005) Evolution of methodological standards in surgical trials. ANZ J Surg 75(10):874–877. doi:10.1111/j.1445-2197.2005.03554.x
PubMed
Article
Google Scholar
Jacquier I, Boutron I, Moher D, Roy C, Ravaud P (2006) The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement—a systematic review. Ann Surg 244(5):677–683. doi:10.1097/01.sla.0000242707.44007.80
PubMed Central
PubMed
Article
Google Scholar
Potter S, Brigic A, Whiting PF, Cawthorn SJ, Avery KNL, Donovan JL, Blazeby JM (2011) Reporting clinical outcomes of breast reconstruction: a systematic review. J Natl Cancer Inst 103(1):31–46. doi:10.1093/jnci/djq438
CAS
PubMed
Article
Google Scholar
Blencowe NS, Strong S, McNair AGK, Brookes ST, Crosby T, Griffin SM, Blazeby JM (2012) Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg 255(4):658–666. doi:10.1097/SLA.0b013e3182480a6a
PubMed
Article
Google Scholar
Abalos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P (2013) Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. Lancet 382(9888):234–248. doi:10.1016/s0140-6736(13)60441-9
CAS
PubMed
Article
Google Scholar
INVOLVE Supporting public involvement in NHS, public health and social care research. http://www.invo.org.uk/. Accessed 30 September 2013
The James Lind Alliance. http://www.lindalliance.org/. Accessed 18 September 2013
Fleurence R, Selby JV, Odom-Walker K, Hunt G, Meltzer D, Slutsky JR, Yancy C (2013) How the patient-centered outcomes research institute is engaging patients and others in shaping its research agenda. Health Aff 32(2):393–400. doi:10.1377/hlthaff.2012.1176
Article
Google Scholar
Royal College of Surgeons of England. http://www.rcseng.ac.uk/. Accessed 18 September 2013
Surgical trainee collaboratives. http://www.asit.org/resources/collaboratives. Accessed 20 September 2013
Bhangu A, Kolias AG, Pinkney T, Hall NJ, Fitzgerald JE (2013) Surgical research collaboratives in the UK. Lancet 382:1091–1092
PubMed
Article
Google Scholar
Surgical research: the reality and the IDEAL (2009) Lancet 374(9695):1037–1037
Article
Google Scholar
Medical Research Council Network of hubs for trials methodology research. http://www.methodologyhubs.mrc.ac.uk/. Accessed 18 September 2013
American College of Surgeons Continuous Quality Improvement Surgical Research Committee. http://www.facs.org/cqi/src/. Accessed 18 September 2013
Rahbari NN, Diener MK, Fischer L, Wente MN, Kienle P, Buechler MW, Seiler CM (2008) A concept for trial institutions focussing on randomised controlled trials in surgery. Trials 9. doi:10.1186/1745-6215-9-3
Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KGM (2001) Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg 88(9):1157–1168. doi:10.1046/j.0007-1323.2001.01829.x
CAS
PubMed
Article
Google Scholar
Whistance RN, Forsythe RO, McNair AG, Brookes ST, Avery KN, Pullyblank AM et al (2013) A systematic review of outcome reporting in colorectal cancer surgery. Colorectal Dis 15(10):e548–e560
CAS
PubMed
Article
Google Scholar
Chan AW, Altman DG (2005) Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. Br Med J 330(7494):753. doi:10.1136/bmj.38356.424606.8F
Article
Google Scholar
Hannink G, Gooszen HG, Rovers MM (2013) Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg 257(5):818–823. doi:10.1097/SLA.0b013e3182864fa3
PubMed
Article
Google Scholar
Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E et al (2008) Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 3(8)
Dwan K, Kirkham JJ, Williamson PR, Gamble C (2013) Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis. BMJ Open 3(6)
Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, Williamson PR (2010) The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340. doi:10.1136/bmj.c365
COMET (Core Outcome Measures in Effectiveness Trials) Initiative. http://www.comet-initiative.org/. Accessed 19 September 2013
Macefield RC, Jacobs M, Blencowe NS, Korfage IJ, Nicklin J, Brookes ST, Sprangers MAG, Blazeby JM (2011) The case for a HRQL core outcome set: outcome reporting bias in oesophageal cancer studies. Trials 12(Suppl 1):A77
PubMed Central
Article
Google Scholar
Whistance RN, Blencowe NS, Blazeby JM (2012) The need for standardised outcome reporting in colorectal surgery. Gut 61(3):472–472. doi:10.1136/gutjnl-2011-300676
CAS
PubMed
Article
Google Scholar
Schulz KF, Grimes DA (2002) Blinding in randomised trials: hiding who got what. Lancet 359(9307):696–700. doi:10.1016/s0140-6736(02)07816-9
PubMed
Article
Google Scholar
Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, Ravaud P (2007) Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 4(2):e61. doi:10.1371/journal.pmed.0040061
PubMed Central
PubMed
Article
Google Scholar
Boutron I, Tubach F, Giraudeau B, Ravaud P (2003) Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. J Am Med Assoc 290(8):1062–1070. doi:10.1001/jama.290.8.1062
Article
Google Scholar
Boutron I, Tubach F, Giraudeau B, Ravaud P (2004) Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol 57(6):543–550. doi:10.1016/j.jclinepi.2003.12.010
PubMed
Article
Google Scholar
Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP (2002) A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 347(2):81–88. doi:10.1056/NEJMoa013259
PubMed
Article
Google Scholar
Freed CR, Greene PE, Breeze RE, Tsai WY, DuMouchel W, Kao R, Dillon S, Winfield H, Culver S, Trojanowski JQ, Eidelberg D, Fahn S (2001) Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med 344(10):710–719. doi:10.1056/nejm200103083441002
CAS
PubMed
Article
Google Scholar
Wolsko PM, Eisenberg DM, Simon LS, Davis RB, Walleczek J, Mayo-Smith M, Kaptchuk TJ, Phillips RS (2004) Double-blind placebo-controlled trial of static magnets for the treatment of osteoarthritis of the knee: results of a pilot study. Altern Ther Health Med 10(2):36–43
PubMed
Google Scholar
Raviele A, Giada F, Menozzi C, Speca G, Orazi S, Gasparini G, Sutton R, Brignole M (2004) A randomized, double-blind, placebo-controlled study of permanent cardiac pacing for the treatment of recurrent tilt-induced vasovagal syncope. The vasovagal syncope and pacing trial (SYNPACE). Eur Heart J 25(19):1741–1748. doi:10.1016/j.ehj.2004.06.031
PubMed
Article
Google Scholar
Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC (2003) The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med 139(4):237–243
CAS
PubMed
Article
Google Scholar
Vitek JL, Bakay RA, Freeman A, Evatt M, Green J, McDonald W, Haber M, Barnhart H, Wahlay N, Triche S, Mewes K, Chockkan V, Zhang JY, DeLong MR (2003) Randomized trial of pallidotomy versus medical therapy for Parkinson’s disease. Ann Neurol 53(5):558–569. doi:10.1002/ana.10517
PubMed
Article
Google Scholar
Quinn J, Cummings S, Callaham M, Sellers K (2002) Suturing versus conservative management of lacerations of the hand: randomised controlled trial. Br Med J 325(7359):299
Article
Google Scholar
Gervaz P, Inan I, Perneger T, Schiffer E, Morel P (2010) A prospective, randomized, single-blind comparison of laparoscopic versus open sigmoid colectomy for diverticulitis. Ann Surg 252(1):3–8. doi:10.1097/SLA.0b013e3181dbb5a5
PubMed
Article
Google Scholar
Ezra E, Gregor ZJ (2004) Surgery for idiopathic full-thickness macular hole: two-year results of a randomized clinical trial comparing natural history, vitrectomy, and vitrectomy plus autologous serum: Morfields Macular Hole Study Group Report no. 1. Arch Ophthalmol 122(2):224–236. doi:10.1001/archopht.122.2.224
PubMed
Article
Google Scholar
Chan A-W, Tetzlaff JM, Altman DG, Dickersin K, Moher D (2013) SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 381(9861):91–92. doi:10.1016/s0140-6736(12)62160-6
PubMed
Article
Google Scholar
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD (2013) Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. J Am Med Assoc 309(8):814–822. doi:10.1001/jama.2013.879
CAS
Article
Google Scholar
Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC (2011) The ClinicalTrials.gov results database–update and key issues. N Engl J Med 364(9):852–860. doi:10.1056/NEJMsa1012065
CAS
PubMed Central
PubMed
Article
Google Scholar
Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM (2007) Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 25(21):3061–3068. doi:10.1200/jco.2006.09.7758
PubMed
Article
Google Scholar
CORONIS: International study of caesarean section surgical techniques: the follow-up study. (2012). https://www.npeu.ox.ac.uk/files/downloads/coronis-follow-up/CORONIS-Follow-up-Protocol-V5-Nov-2012.pdf. Accessed 04 October 2013
Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ (2010) Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med 362(20):1863–1871. doi:10.1056/NEJMoa0909305
PubMed
Article
Google Scholar
King PM, Blazeby JM, Ewings P, Franks PJ, Longman RJ, Kendrick AH, Kipling RM, Kennedy RH (2006) Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. Br J Surg 93(3):300–308. doi:10.1002/bjs.5216
CAS
PubMed
Article
Google Scholar
Grant AM, Cotton SC, Boachie C, Ramsay CR, Krukowski ZH, Heading RC, Campbell MK (2013) Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX). Br Med J 346:f1908. doi:10.1136/bmj.f1908
CAS
Article
Google Scholar
Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW (2013) Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 381(9867):629–638. doi:10.1016/s0140-6736(13)60141-5
PubMed
Article
Google Scholar